Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
TIAMULIN
Novartis Animal Health UK Ltd
QJ01XQ01
TIAMULIN
200 Mg/Ml
Solution for Injection
POM
Porcine
Tiamulin
Antibacterial
Transfer Pending
2010-04-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Denagard 200 mg/ml solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. A clear, yellow, oily solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Porcine. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of swine dysentery caused by _Brachyspira hyodysenteriae _complicated by _Fusobacterium_ spp. and _Bacteroides _spp. For the treatment of enzootic pneumonia and mycoplasmal arthritis. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For intramuscular injection of pigs only. Each ml contains: ACTIVE SUBSTANCE Tiamulin base 162.2 mg (equivalent to tiamulin hydrogen fumarate 200.0 mg) EXCIPIENTS Ethanol 50.0 mg For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 11/09/2015_ _CRN 7019104_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Ensure dry syringe is used. Accidental self-injection of oily preparations may cause serious localised reactions. If accidental injection occurs go immediately to the casualty department of the nearest hospital as special treatment may be necessary. Take the pack or package leaflet to show the doctor, who should be informed that the product contains oil. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin. 4.7 Izlasiet visu dokumentu